What you say is true if the regulators are acting on a BLA which should be based on the SAP. I really can't speak of the others beyond the FDA, but I suspect most of them will take roughly 6 months after the BLA is submitted to decide, like the FDA does.
If we gain top line results before year's end, I frankly doubt a BLA submission will occur before near the end of the second quarter of next year, and perhaps later. That would make approval, or denial, at near the end of 2020, or later. That leaves a great deal of time for things like a partnership, or buyout, either way, the stock price should move up dramatically. I don't know just how high the price may go, in part it might be based on DCVax-Direct if new interim trial results came in before then. I certainly believe our share price could be in the $5 to $10 range if we have a partner, and in the worst case, if the regulators want an additional trial, the partner would pay. It wouldn't be a good thing, but with funding established investors would recognize it as a delay, the approval would still be inevitable.
First thing is seeing the top line data, I certainly believe if 70 patients or more are still alive, at least a dollar should be certain. If that number is in the 80's, $2 or more is very possible as practically no one would have passed on since the last time a number was seen. I believe that when we hear about those living in the trial we may learn that many don't have detectable cancer. It doesn't mean they're cured, even if it's beyond 5 years, but they're probably not seeing their oncologist very often, unless they're concerned about something. I'm not quite 5 years past receiving stem cells and I go in quarterly, by next year I wouldn't be surprised if it became semi-annually. I believe our vaccine has that sort of capability. One nice thing about City of Hope is that they keep in touch with patients, even those cancer free for decades typically come in once a year, and they also get thousands on the day they have their transplant reunion.
Gary
